TECNIS CL IOL Z9002 (REF Z900200245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474530782), received between Mar 15, 2017 and Mar 5, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2024Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HAD CLOUDINESS IN THE LEFT EYE AFTER IMPLANTATION OF THE NON PRELOADED INTRAOCULAR LENS (IOL). THE IMPLANT WAS PLACED 7-8 YEARS AGO. THE LENS WAS NOT REPLACED. IT IS REPORTED THAT THE EXPLANT OF LENS WILL OCCUR IN THE NEXT COUPLE OF WEEKS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 18841151 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD OTHER VISUAL DISTURBANCE-COULD NOT TOLERATE MONO VISION WITH AN INTRAOCULAR LENS (IOL). THEREFORE, THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Discomfort

  MAUDE report 11314208 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT'S DAUGHTER REPORTED THAT HER MOTHER HAS BEEN HAVING LIGHT SENSITIVITY ISSUE SINCE HER CATARACT SURGERY. THE PATIENT STARTED TO EXPERIENCE PAIN AROUND THE LEFT EYE SOMETIME IN (B)(6) 2017. WHEN THIS OCCURRED THE PAIN LEVEL WAS BETWEEN 5-6. THE PATIENT SHARED THIS INFORMATION WITH HER DOCTOR IN (B)(6) 2018 AND WAS PRESCRIBED WITH SOME EYE DROPS FOR THE PAIN. THE DOCTOR INFORMED THE PATIENT THAT THE PAIN IS DUE TO THE SURGERY, SO SHE CONTINUED TO USE THE EYE DROP WHEN SHE WAS EXPERIENCING THE PAIN WHICH REPORTEDLY COMES AND GOES. THE PATIENT CHANGED INSURANCE AND SWITCHED DOCTOR AND THE NEW DOCTOR ADVISED HER TO STOP USING THE EYE DROP FOR PAIN. THE PATIENT IS CURRENTLY NOT USING ANYTHING FOR THE PAIN. IT WAS INDICATED THAT THE PATIENT STILL OCCASIONALLY FEELS PAIN AROUND HER LEFT EYE AND THE PAIN LEVEL IS 3. IT WAS NOTED THAT THE LIGHT SENSITIVITY STARTED MIDDLE OF 2018. THE LIGHT SENSITIVITY WAS COMMUNICATED TO THE PATIENT'S NEW DOCTOR WHO CHECKED THE IMPLANT AND TOLD THE PATIENT THAT THE LEFT LENS DOESN¿T APPEAR TO BE CENTERED. THE DOCTOR ALSO TOLD THE PATIENT TO CONTINUE USING THE EYE DROP FOR DRY EYES AND THAT SHE WOULD NEED TO USE SUNGLASSES. THE PATIENT INDICATED TO H

  Patient problems: No Code Available; Pain; Visual Disturbances

  MAUDE report 9737392 ↗
• InjuryDec 13, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9468512 ↗
• MalfunctionJul 3, 2019Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE DOCTOR NOTICED A BROKEN HAPTIC PROBABLY DUE TO A LOADING ISSUE. THE LENS WAS REMOVED AND REPLACED AND THERE WERE NO PATIENT PROBLEMS. A FOLDING PROBLEM WAS ALSO REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8760975 ↗
• MalfunctionNov 13, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A Z9002 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED SCRATCHED AFTER BEING INSERTED INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS CUT IN HALF AND REMOVED. THERE WAS NO INCISION ENLARGEMENT REPORTED. THE LENS WAS REPLACED WITH A NEW LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7026377 ↗
• InjuryMar 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SYMPTOMS WITH THE INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN 2009. REPORTEDLY, WHILE SNOWFLAKE DEBRIS/DEPOSIT APPEARS ON THE LENS AND CAN NOT BE LASERED OFF WITH THE YAG LASER. PATIENT COMPLAINS OF DIFFICULTY WITH FILMY VISION WHICH BEGAN 6 MONTHS AGO AND IS AFFECTING BOTH HER EYES. THE EPISODE WAS GRADUAL. THE PATIENT DESCRIBES DRY AND HAZY SYMPTOMS AFFECTING HER EYES/VISION. THE CONDITION'S SEVERITY IS MODERATE. THE PATIENT EXPERIENCED DRY EYES WHICH STARTED 6 MONTHS AGO AND BOTH EYES ARE AFFECTED. THE EPISODE IS GRADUAL AND PATIENT DESCRIBES GLAZY AND HAZY SYMPTOMS AFFECTING BOTH EYES. THE CONDITION'S SEVERITY HAS INCREASED SINCE THE PATIENT'S LAST VISIT. THE CONDITION IS WORSE WITH DAILY ACTIVITIES. THE PATIENT WAS TO RETURN FOR A DIABETES FOLLOW-UP ON BOTH EYES. SINCE HER LAST VISIT, THE AFFECTED AREA HAS NO CHANGES NOTED. THE PATIENT'S VISION IS STABLE. THE DOCTOR WILL CONSIDER A LENS EXCHANGE IF THE PATIENT IS STILL BOTHERED WITH HER VISUAL ACUITY AFTER HER EYE GLASSES PRESCRIPTION IS UPDATED. PATIENT'S DISTANCE VISION WAS 20/50 SC (SANS CORRECTED). NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAS TWO LENSES IMPLANTED; T

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 6408313 ↗